Basic Purposes & Scope主要目的和職責范圍
Start-up phase:項目階段
-Provide strong support for production line transferring, guide the process validation implementation to comply with the quality system & rent regulations，review and carry out s to reduce the risk of process validation failure 支持生產線轉移，指導過程確認的實施以符合相關質量體系和法規要求，評審并采取措施以降低過程確認的失敗風險
-Build up testing capacity regarding products, including setting up inspection procedures, product specifications and qualify testing equipment. 建立和產品相關的測試能力，包括建立測試程序，產品標準并驗證測試設備
-Set up and follow up the quality control plan 建立并跟蹤質量控制計劃
- Take part in process validation. 參與過程確認
Build up testing capacity regarding products, including setting up inspection procedures, product specifications and qualify testing equipment. 建立和產品相關的測試能力，包括建立測試程序，產品標準并驗證測試設備
Operate inspection procedures 執行測試程序
Train and qualify LQC 培訓及考核LQC
Set up and follow up the quality control plan建立并跟蹤質量控制計劃
Routine production:日常生產
-Perform WIP product release, and complete quality report 實施WIP產品放行，完成質量報告
-Identify NCs and CAPAs in a systematic way, e.g. using statistical tools 系統地識別不合格和CAPA，例如，運用統計工具
-Take responsibility for quality improvement 負責質量改進
-Cooperate with other Engineers for complaint investigation and close 與其它工程師協作完成投訴處理
- Perform batch record review to develop quality metric and drive defect reduction effort. 實施批記錄審閱，建立質量指標并驅動降低不良
Perform statistical analysis of process data interpret, compile and organize results. 實施過程數據的統計分析，解析并編輯組織
Address product quality issues and organize quality improvement 識別質量問題，組織質量改進
Cooperate with other Engineers for failure investigation, including NCR, deviation and complaint, etc與其它工程師協作完成實效調查，包括不合格、偏差和投訴
Authorize to release in-process product & FG(If they meet the pre-defined spec) relating to his/her responsible product line. 授權放行與其責任產品相關半成品和成品
Other tasks defined in QMS. QMS 定義的其他職責
Comply with Company’s EHS policies, regulations and procedures

Job Specifications職位要求
- A bachelors degree in scientific or engineering discipline.
本科學歷，科學或工程背景
- Mechanical or Electrical education as a plus
機械或電子教育背景優先考慮
-Minimum 4 years experience in quality field in manufacturing environment. 至少4年生產質量經驗
-Experience in medical device and/or knowledge of a wide range of manufacturing technologies is desired. 醫療器械知識，通曉生產技術
- Experience in sterile device manufacturing as a plus
無菌器械生產優先考慮
- Understand requirements of process/equipment validation
了解過程/設備確認
- 6 sigma certificate as a plus
具有6 sigma 證書優先考慮
- Fluent verbal and written English 流利的讀寫英語
- Good computer skill of Microsoft application software
計算機操作（微軟應用程序）
- Good communication skill and team spirit
良好的溝通能力和團體合作精神

Medtronic和Covidien攜手合作，通過更多方式以及在全球更多地方改善醫療保健，以滿足更多人的需求。作為一家公司，我們促進并增強實現有意義創新的能力。但是，要取得成功，我們的團隊必須擁有優秀的人才。現在是加入我們并為改善更多人的健康作出貢獻的理想時機。

通過整合Medtronic和Covidien的資源，我們具備改革能力，并創造全新方法和新機遇。不論您的專長領域或理想抱負為何，Medtronic都會讓您大放光彩，讓您在幫助更多人改善生活的同時拓展自己的職業生涯。

Medtronic是一家市值278億美元的公司，它在全球超過160個國家擁有85000+名員工。

Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.